Kornimate/medical-research-clean huggingface dataset:
observational study of patients treated with nivolumab and chemotherapy for advanced or metastatic esophageal, gastroesophageal or gastric cancer in france

Conditions: Gastric Adenocarcinoma; Gastro-esophageal Junction Adenocarcinoma; Esophageal Adenocarcinoma (EAC); Esophageal Squamous Cell Carcinoma (ESCC)

Summary: a study to estimate the overall survival in real-life conditions in france of adult participants treated with nivolumab in combination with chemotherapy as first-line treatment for gastric and gastroesophageal junction cancer.


Eligibility criteria:
inclusion criteria: cohorts 1 \& 2 * adult participants (at least 18 years of age at time of treatment decision) * participants treated with nivolumab in combination with fluoropyrimidine- and platinum-based chemotherapy (according to the french current marketing authorization) for the treatment of gastric adenocarcinoma, gastro-esophageal junction (gej) adenocarcinoma, esophageal adenocarcinoma (eac) or esophageal squamous cell carcinoma (escc) and prior to study participation. * participants who provided oral informed consent to participate in the study cohort 1 only • diagnosis of untreated her2 negative advanced or metastatic gastric adenocarcinoma, gej adenocarcinoma or eac whose tumor express pd-l1 with a cps ≥5 cohort 2 only • diagnosis of untreated unresectable advanced, recurrent or metastatic escc with tumor cell pd-l1 expression (tps) ≥1% exclusion criteria: cohorts 1 \& 2 * participants with a primary diagnosis of a cancer other than advanced or metastatic gastric adenocarcinoma, gej adenocarcinoma, eac or escc, within the past 5 years. * participants currently enrolled in an interventional clinical trial for his/her advanced or metastatic gastric adenocarcinoma, gej adenocarcinoma, eac or escc. * pregnant women * participants under guardianship

Keywords: gastric adenocarcinoma gastro-esophageal junction (gej) adenocarcinoma esophageal adenocarcinoma (eac) esophageal squamous cell carcinoma (escc)
microbiome in atopic dermatitis under systemic therapy

Conditions: Atopic Dermatitis

Summary: the skin microbiome plays a role in the pathogenesis of atopic dermatitis. however, it is unclear whether the range of microbiota on the skin is the cause or consequence of atopic skin inflammation. the influence of new systemic therapies for the treatment of moderate to severe atopic dermatitis (such as biologics or janus kinase inhibitors) on the skin microbiome is largely unknown. the main aim of this scientific exploratory study is to investigate whether and how the skin microbiome changes in patients with moderate to severe atopic dermatitis during systemic therapy. this not only allows new hypotheses to be generated on the pathogenesis of atopic dermatitis, but also new objective scales for the severity of atopic dermatitis can be developed.

a better understanding of the pathology of atopic dermatitis could lead to the development of new therapeutic strategies for this disease and contribute to better and more targeted disease management - an advantage for all patients with atopic dermatitis. the routine examinations are carried out every quarter with routine visits over two years. the dates before, 6, 12, and 24 months after the initiation of systemic therapy are relevant for this study. deviations from normal practice are not intended. patients in whom a new initiation of systemic therapy is planned will be invited for a follow-up 6 weeks after initiation and quarterly follow-up visits. blood samples must be obtained for the examination. the blood is taken to determine the systemic level of inflammatory mediators (serological biomarkers, pbmcs) and for genetic examinations (e.g. filaggrin gene mutation - flg) as well as mrna / lncrna profile. the skin physiological examinations are not invasive or pain-related procedures. microbiome sampling will be conducted by a skin swab of the inter-scapular region. the blood / skin samples taken as part of this scientific study are pseudonymized in the research laboratories. the samples are stored in the laboratories for a period of 5 years after the end of the study and then destroyed.

Eligibility criteria:
inclusion criteria: * patients with moderate to severe atopic dermatitis * indication for systemic therapy exclusion criteria: * patients under 18 years of age upon introducing systemic therapy * pregnant and lactating women

Keywords: dupilumab cyclosporine skin microbiome baricitinib
study of cognitive inhibition disorders in depressed older suicide attempters

Conditions: Suicide, Attempted; Cognitive Symptoms

Summary: the purpose of this study is to compare the cognitive inhibition deficit among depressed older suicide attempters compared to depressed older suicide non-attempters.

the main objective consists in examining the association between cognitive inhibition and suicide attempt in depressed older adults (\> 65 year old).

Eligibility criteria:
inclusion criteria: * age \> 65 years old * score of mini-mental state examination (mmse) \> 23 * score of hamilton depression scale \>27 * for group 1 (depressed older suicide non-attempters): no history of suicide attempt * for group 2 (depressed older suicide attempters) : history of suicide attempt exclusion criteria: * neurological history or medical-surgical affection in the past 3 months. * dependence or alcohol abuse. * use of neuroleptics

Keywords: suicide, attempted cognitive symptoms
iron overload in stem cell transplant recipients

Conditions: Iron Overload

Summary: the goal of this study is to examine the impact of iron overload in patients undergoing a bone marrow transplant. we believe that the iron status in these patients is associated with complications for transplant survivors. we will examine the iron status in these patients by mri and by screening for mutations in genes known to cause iron overload. we will also determine the levels of hepcidin (a hormone produced in the liver that appears to regulate iron homeostasis) from blood and urine.


Eligibility criteria:
1. undergoing allogeneic hsct for malignant or non-malignant conditions 2. age greater than or equal to 5 years 3. able to undergo mri without a need for general anesthesia 4. no metal implants 5. signed informed consent (by parent if patient is less than 18 years old, or by patient, if he or she is greater than 18 years old).

Keywords: hemochromatosis iron overload stem cell transplant pediatrics pediatric stem cell transplant
study of tesomet with open-label extension in subjects with hypothalamic obesity (ho)

Conditions: Hypothalamic Obesity

Summary: this study will evaluate the safety and efficacy of tesomet (tesofensine + metoprolol) in subjects 18 years of age or older, with ho


Eligibility criteria:
key inclusion criteria: * subject and, if applicable, their parent or legal guardian must be willing to provide informed consent * diagnosis of ho secondary to damage to the hypothalamus * female subjects must be of non-childbearing potential * at least 6 months since completion of therapy (chemotherapy, surgery, or radiation with resulting injury to the hypothalamus and/or the pituitary) with stable disease and lack of recurrence * bmi 30.0 to 60.0 kg/m², inclusive * documented stable body weight (gain/loss \<10%) for at least 90 days prior to screening * stable and well-managed pituitary replacement (eg, glucocorticoid, thyroid hormone, estrogen/progestin or testosterone, desmopressin, or growth hormone) for \>2 months prior to screening * male subjects who are sexually active must be surgically sterile key exclusion criteria: * females who are pregnant, breastfeeding, or actively intending to become pregnant during the study * sitting bp that meets the following criteria after 5 minutes of rest at screening: 1. systolic bp \>145 mmhg or \<100 mmhg; or 2. diastolic bp \>95 mmhg or \<70 mmhg * type 1 diabetes mellitus * history of major depressive disorder within 2 years prior to screening, or any history of other severe psychiatric disorder (eg, schizophrenia, bipolar disorder) * uncontrolled endocrine disorders (eg, cushing syndrome, addison's, hypothyroidism, hyperthyroidism) * history of bulimia or anorexia nervosa * use of prohibited medications, including current use of selective serotonin reuptake inhibitors / serotonin-norepinephrine reuptake inhibitors (ssris/snris)
ivig and rituximab in antibody-associated psychosis - sinapps2

Conditions: Psychosis; Autoimmune Encephalitis

Summary: a randomised phase ii double-blinded placebo-controlled trial designed to explore the utility of immunotherapy for patients with acute psychosis associated with anti-neuronal membranes (nmda-receptor or voltage gated potassium channel). primary objective: to test the efficacy of immunotherapy (ivig and rituximab) for patients with acute psychosis associated with anti-neuronal membranes. secondary objective: to test safety of immunotherapy (ivig and rituximab) for patients with acute psychosis associated with anti-neuronal membranes.

investigators propose a randomised double-blinded placebo-controlled trial to test the hypothesis that immunotherapy is an effective treatment of antibody-associated psychosis, either first episode of psychosis or relapse following previous remission. immunotherapy for the trial consists of one cycle of intravenous immunoglobulin (ivig: 2g/kg over days 1-4) followed by two infusions of 1g rituximab (at day 28-35, and then 14 days after the first infusion). the rationale for this regime is that it combines a rapid-action treatment (ivig) to induce remission with a longer-action therapy (rituximab) to maintain remission. it is based on a protocol where elimination of circulating antibodies is the treatment goal, namely "desensitisation" of potential transplant patients who have multiple anti-hla antibodies capable of inducing hyperacute rejection and also being tested in various trials on clinicaltrials.gov (nct00642655, nct01178216, and nct01502267). blinding is required to minimise placebo responses in a trial based on symptomatology.

Eligibility criteria:
inclusion criteria: * acute psychosis \>2 weeks. this may either be first episode or relapse after remission (remission defined as having mild or absent symptoms of psychosis for at least 6 months) * serum or csf neuronal membrane autoantibodies at pathological levels (including nmdar, lgi1 and other) * psychosis symptoms as defined by panss ≥4 on at least one of the following items: p1, p2, p3, n1, n4, n6, g5 and g9. exclusion criteria: * current episode of psychosis greater than 24 months duration * co-existing severe neurological disease * evidence of current acute encephalopathy * hepatitis or hiv infection, pregnancy * contraindications to any trial drug * concurrent enrolment in another ctimp

Keywords: psychosis immunotherapy autoantibodies
external vs internal-triggered augmented-reality visual cues to treat freezing of gait

Conditions: Parkinson Disease; Gait Disorders, Neurologic; Parkinsonian Disorders; Movement Disorders; Gait, Unsteady; Gait, Festinating

Summary: postural instability, freezing-of-gait (fog), and falls are among the greatest unmet needs in parkinson disease (pd). fog eventually affects more than half of people with pd, and is notoriously difficult to treat pharmacologically or via deep brain stimulation. visual cues do improve gait freezing, but their efficacy and adoption is limited because they are not practical to use in all real-world situations. there is a need for a cueing technique that is on-demand and discreet - only perceptible to the patient. fortunately, recent technological advances in augmented-reality (ar) enable such an approach. in this study, state-of-the-art ar glasses will be used to project digital cues that are only visible to the wearer, to determine if they can improve fog. 36 individuals with pd and fog will be recruited to perform an obstacle-course gait task under six cue conditions: no cue, conventional cue, constant-on ar, patient-hand-triggered ar (turns on when patient clicks button), patient-eye-triggered ar (turns on when looking down), and examiner-triggered ar. the ar cue is a set of images that appear on the floor at a patient's feet, mimicking floor lines. gait performance will be captured on video and via body-worn wireless sensors that detect how each limb is moving. the investigators will determine whether individuals are cue-able with conventional visual cues, whether intermittent cues outperform constant-on cues, and whether cues triggered by an examiner outperform cues triggered by patients themselves.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of pd * presence of freezing of gait, defined as a score of ≥1 in mds-updrs 2.13, or 3.11. * can walk without assistance, off meds, based on yes/no verbal response exclusion criteria: * severity of gait impairment should not require dependency to walker or cane * concomitant conditions that may affect significantly the evaluation of balance or gait, including orthopedic, rheumatologic or other neurological diseases * contraindication to physical therapy * severe bilateral visual impairment * age \< 21 * diagnosis of dementia * not agreeable to having video taken of entire research visit

Keywords: parkinson disease freezing of gait fog pd augmented reality cue cueing visual gait freezing
creatine metabolism in rett syndrome

Conditions: Rett Syndrome

Summary: rett syndrome (rtt) is an x-linked severe neurodevelopmental disorder. despite their good appetite, many females with rtt meet the criteria for moderate to severe malnutrition. the pathological mechanism is barely understood. although feeding difficulties may play a role in this, other constitutional factors as altered metabolic processes are suspected. preliminary research showed elevated plasma creatine concentrations and increased urinary creatine/creatinine ratios in half of the rtt girls. the aim of this study is to confirm previous findings and examine the functionality of the creatine transporter in rtt girls. the investigators assume that previous findings will be confirmed, and are due to an altered functionality of the creatine transporter.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of rtt (meeting consensus diagnostic criteria (hagberg et al, 2002)); * mecp2-mutation; * complete neurophysiological work-up; * participant preliminary research (research protocol nl25356.068.08). exclusion criteria: * male gender

Keywords: rett syndrome nutritional status creatine metabolism
ustekinumab with semi-en vs exclusive en for preoperative crohn's disease optimization.

Conditions: Crohn Disease (CD)

Summary: ustekinumab (ust) is a novel biologic agent that targets and binds to interleukin-12 (il-12) and interleukin-23 (il-23), and is approved for inducing and maintaining remission in crohn disease(cd). currently, it is believed that the use of ust for the preoperative treatment of cd patients is generally safe and does not increase surgical complications, and it can be used for preoperative treatment of cd. however, there is still a lack of literature reporting the role of ust in preoperative optimization for cd. semi-enteral nutrition refers to the provision of more than 50% of the energy required by the human body through enteral nutrition preparations. semi-enteral nutrition can improve the nutritional status of patients with cd, but it does not induce remission of active disease. the treatment method of ust combined with semi-enteral nutrition can not only induce disease remission, but also improve the nutritional status of patients. therefore, can the combined treatment regimen replace exclusive enteral nutrition (een) as a new therapy for preoperative optimization of cd? at present, there is a lack of relevant research, so this study intends to conduct a multi-center, prospective, randomized controlled trial to compare the efficacy differences between ust+semi-enteral nutrition and een in preoperative optimization for cd, and to clarify the preoperative optimization effect of ust combined with semi-enteral nutrition therapy.


Eligibility criteria:
inclusion criteria: * cd patients with surgical indications, who are scheduled for partial intestinal resection and anastomosis; * cd patients diagnosed prior to surgery; * patients aged 18-65; * cdai score of \>150; * for patients with peritoneal abscess, they must receive adequate antibiotics and drainage prior to enrollment, and be confirmed to be free of infection before enrolling in the study; * the patients agree to participate in the study and sign an informed consent form; * patients who have not used ustekinumab prior to surgery; * patients who have tried other treatments and found them ineffective, and plan to stop using them and schedule surgery. exclusion criteria: * emergency surgery; * had received exclusive enteral nutrition support within 3 months prior to surgery; * unable to tolerate enteral nutrition; * failed with ust; * pregnant or with co-existing intestinal outside organ dysfunction, tumor, rheumatological or immunological diseases, etc.
gustin gene polymorphism and 6-n-propylthiouracil (prop) taste

Conditions: Dysgeusia

Summary: the investigators evaluate the possible association of prop taste with gustin gene polymorphism rs2274333 (a/g), salivary zinc ion concentration and bmi. in addition, it has also been evaluated prop taste sensitivity by recording monophasic potentials from the tongue.

the investigators evaluate the possible association of prop taste with gustin gene polymorphism rs2274333 (a/g), salivary zinc ion concentration and bmi. furthermore, we apply direct measures of the gustatory system activation following stimulation with prop, obtained by electrophysiological recordings from the tongue of subjects classified for taster status, genotyped for the specific receptor gene (tas2r38), and in which papilla density was determined.

Eligibility criteria:
inclusion criteria: * no variation of body weight \> 5 kg over the last 3 mo bmi within 20-25 age between 20-30 exclusion criteria: * gustatory impairment following a prescribed diet or using medications that might interfere with taste perception food allergies smokers

Keywords: prop taste sensitivity gustin (cavi) polymorphism salivary zinc bmi electrophysiological recording from the tongue
kardiamobile ecg monitoring effects on health care utilization and patient experience with atrial fibrillation

Conditions: Atrial Fibrillation (AF)

Summary: this is a two-center, randomized controlled trial of 100 patients comparing intervention (kardiamobile) with standard of care. kardia mobile is an fda approved device that allows one- or six lead ecg recording for 30 seconds using the patient's smart phone. the device has a automated algorithm that interprets the ecg as either sinus rhythm, af, or unclassified. the intervention arm will be given a kardiamobile device, free of charge, to be synched to their smartphone at the time of enrollment. they will be instructed on proper device procedure and will use the device with the onset of potential af-related symptoms (e.g. chest pressure, palpitations, lightheadedness, syncope, shortness of breath, or other symptoms concerning for a cardiac etiology) or when requested to do so by their healthcare provider. the device ecg recordings will be transmitted to participants physicians through mychart who will incorporate this information into the patient's treatment as indicated. all files will be stored on a private, secure platform and any subsequent communication from the clinical team will occur via standard clinical channels (mychart or telephone contact). healthcare utilization will be assessed by having the participants in both groups complete a questionnaire asking how many times they used their kardiamobile device (if randomized to this group) and how many office appointments, emergency department visits, and hospital admissions they had within that six-month period.


Eligibility criteria:
inclusion criteria: * 18-90 years of age, * diagnosis of atrial fibrillation within the last 6 months, * possession of a smart phone with active cell service, * physical and cognitive ability to self-record reliable ecg tracings on the kardiamobile device, * life expectancy \>12 months. exclusion criteria: * resting tremor * has an intracardiac lead. * has an implanted loop recorder. * already has an apple watch, fitbit, or other mobile ecg recorder. * those who are non-english speaking, pregnant, or a prisoner.
clinical trial of a mouth and throat rinse for the treatment of acute sore throat

Conditions: Sore-throat; Upper Respiratory Infection

Summary: the aim of this study is to confirm the efficacy, safety and tolerability of the mouth and throat rinse in adult participants with acute sore throat (upper respiratory tract infection e.g., pharyngitis/laryngitis) compared to placebo.


Eligibility criteria:
inclusion criteria: * subjects having clinical signs and symptoms of recent (less than 48 h) acute sore throat (upper respiratory tract infection) without signs of lower respiratory tract infection (total severity score for throat irritation baseline value ≥ 4). * centor score of 0 to 3 points at screening. * female and male subjects with 18-75 years of age. exclusion criteria: * known allergy to any of the components in the investigational product (placebo or verum) (i.e. sls). * centor score of 4 points at screening. * presence of exanthema. * presence of oral mucosal plaques e.g., soor. * presence of bacterial infection of the upper respiratory tract (confirmed by rapid screening test).